Blood and Lymph Conditions

All Conditions

Neoplasms

Immune System Diseases

Rare Diseases

Thrombocytopenia

Lymphoma

Hodgkin Disease

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Lymphosarcoma

Hodgkin Lymphoma

Planned Cohorts:

1. 100 mcg,
2. 300 mcg,
3. 700 mcg,
4. 1000 mcg;

   Optional Cohorts:
5. cohort expansion,
6. schedule change,
7. new dose

AMG 531

The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.

A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects With Lymphoma.

Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.

Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L, and \<25 x 10\^9/L)

Duration of grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L and \<25 x 10\^9/L, respectively)

Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle

Amgen

Global Development Leader

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Romiplostim 100 µg

Romiplostim 300 µg

Romiplostim 700 µg

Romiplostim 1000 µg

Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy

Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy

Total

Age Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Hispanic or Latino

Race/Ethnicity, Customized

Study Director

Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.

Change in Platelet Nadir

Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia

Duration of Grade 3 or 4 Thrombocytopenia

Percentage of Subjects That Received Platelet Transfusions

Overall Study

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

All Drugs and Chemicals

Maleic acid

Enzyme Inhibitors

30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined:

Lead-In Period (Day 1 - 15)

* Pre-determined dose of Avatrombopag 1x daily.
* Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit).

On-Cycle Period (Day 15 - up to Week 6)

• Pre-determined dose of Avatrombopag 1x daily.

Follow-up Period

* End of Treatment on-site visit.
* Follow-up visit 30-42 days after End of Treatment visit.

30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined:

Lead-In Period (Day 1 - 15)

* Pre-determined dose of matching placebo 1x daily.
* Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit).

On-Cycle Period (Day 15 - up to Week 6)

• Pre-determined dose of matching placebo 1x daily.

Follow-up Period

* End of Treatment on-site visit.
* Follow-up visit 30-42 days after End of Treatment visit.

Thrombopoietin receptor agonist, tablet taken orally.

Avatrombopag

Lactose monohydrate, tablet taken orally.

Matching Placebo

Hanny Al-Samkari, MD

Gerald Soff, MD

Stephen Lattanzi, M.D.

Gerald A Soff, MD

Kanika Nair, M.D.

Joseph Shatzel, M.D.

Sandhya Panch, M.D.

The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy.

The names of the study drugs involved in this study are:

* Avatrombopag (a thrombopoietin receptor agonist)
* Matching placebo

This is a randomized, double-blinded, placebo-controlled, multicenter phase 2 clinical trial evaluating Avatrombopag versus placebo for Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies. Avatrombopag may increase or stimulate megakaryocytes, which aid in producing blood platelets, resulting in an increased production of platelets.

* Participants will be "randomized" into one of the study groups: Group A: Avatrombopag or Group B: Matching placebo. Randomization means that a participant is put into a group by chance.
* All patients who complete the study (whether they received avatrombopag or placebo) have the opportunity to receive avatrombopag to treat CIT through a special free drug program available only to the participants of this study.

The U.S. Food and Drug Administration (FDA) has not approved avatrombopag for CIT, but it has been approved for other uses.

Study procedures include screening for eligibility, treatment visits, and blood tests.

Participants will receive the study treatment or placebo for up to seven weeks and will be followed for up to 42 days after the last dose.

It is expected that about 60 people will take part in this research study.

Swedish Orphan Biovitrum (Sobi), biopharmaceutical company, is supporting this research study by providing the study drugs and funding.

Avatrombopag vs. Placebo for CIT in GI Malignancies

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Avatrombopag for Persistent Chemotherapy-Induced Thrombocytopenia in Patients With Gastrointestinal Malignancies (ACT-GI)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The primary endpoint of this study is the comparison of the response rate between the avatrombopag arm and the placebo arm. A response is defined as achieving a platelet count ≥100,000/µL within the 2 week lead-in period and then finishing at least 1 cycle of chemotherapy without CIT recurrence (no on-cycle dose-reduction or treatment delay due to thrombocytopenia and ability to receive another cycle of chemotherapy without dose-reduction or treatment delay, defined as platelet count of ≥100,000/µL at the start of the following cycle whether or not an additional cycle is planned).

Defined as the composite of successful initial platelet count recovery to ≥100,000/µL within 15 days of initiation of study drug, plus CIT prevention for one additional chemotherapy cycle (including at the completion of that cycle/start of the following cycle).

Assessed by the rate of initial platelet count recovery to ≥100,000/µL during the lead-in period

Assessed by the rate of initial platelet count recovery to ≥100,000/µL during the lead-in period.

The decision on platelet transfusion could be made either because the patient's platelet count is below a threshold, or due to physician's decision. The probability of patients requiring platelet transfusion will be estimated with a 95% confidence interval.

The rate of clinically relevant bleeding will be estimated by the Kaplan-Meier curve. Bleeding events will be graded according to CTCAE and according to the modified WHO bleeding scale. Clinically significant bleeding events will be considered grade II-IV events per this scale.

Thromboembolic events will be graded per CTCAE.

Swedish Orphan Biovitrum

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Gemcitabine

Carboplatin

Cisplatin

Antimetabolites

Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.

Romiplostim

Placebo

The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.

Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum.

This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.

The duration of grade 3 or 4 thrombocytopenia (defined as platelet count \<50 x 10\^9/L) experienced during the first on study chemotherapy cycle by treatment group.

The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count \< 50 x 10\^9/L, but ≥ 25 x 10\^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count \< 25 x 10\^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.

Number of participants who were administered platelet transfusions during first on study treatment cycle.

Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group

Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.

Romiplostim 250 µg

Romiplostim 500 µg

Romiplostim 750 µg

Safety Analysis Set, composed of all randomized participants who received at least one dose of study medication.

Number of Participants With Adverse Events

Efficacy Analysis Set, composed of all randomized participants except those who were replaced (participants who discontinued prior to the completion of at least 1 romiplostim treatment cycle for non-platelet-related reasons).

Efficacy Analysis Set, composed of all randomized participants except those who were replaced.

Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.

Number of Participants With Platelet Transfusions

Efficacy Analysis Set, composed of all randomized participants except those who were replaced

Platelet Count on Day 22

Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle

Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Placebo Oral Tablet

Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer.

Subjects will receive placebo controlled test treatment for one cycle of chemotherapy followed by an observational cycle. Subjects will have the option to continue into an open label extension period for all remaining chemotherapy cycles within the current regimen. After the follow-up visit, all subjects will continue to a long-term safety follow-up period.

Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers

The duration of severe thrombocytopenia is defined as the total number of days with a platelet count \<50×10\^9/L during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2.

Comparison of avatrombopag 60 mg vs. placebo, adjusted for the number of chemotherapy agents currently receiving per IWRS (1, ≥2).

Cycle X nadir is defined as the lowest platelet count value prior to the first dose of study drug; Cycle X+1 nadir is defined as the lowest platelet count value during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day in Cycle X+2.

Sobi, Inc.

Adverse events were assessed by Investigators at each study visit.

Placebo Oral Tablet: Placebo comparator tablet

Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Avatrombopag: Oral avatrombopag tablet

Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Placebo Oral Tablet: Placebo comparator tablet

Age at Enrollment

Age, Continuous

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Subjects with ECOG Score 0

Subjects with ECOG Score 1

Subjects with ECOG Score 2

The Eastern Cooperative Oncology Group (ECOG) performance status score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). 0=Fully active, able to carry on all pre-disease performance without restriction 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2=Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours

ECOG Performance Status

Subjects Receiving 1 Agent

Subjects Receiving ≥ 2 Agents

Number of Eligible Chemotherapy Agents Currently Receiving per IWRS

Baseline Platelet Count (x10⁹/L)

Height (cm)

Weight (kg)

BMI (kg/m²)

VP of Global Drug Development

Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days

Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L

Change in Platelet Count From Baseline (Nadir)

Percentage of Subjects Who Did Not Have Major or Non-major Clinically Relevant Bleeding During the Period After Post-chemotherapy Study Drug Treatment in Cycle X+1 Through Chemotherapy Day of Cycle X+2.

Study is 2:1 randomization ratio (avatrombopag to placebo). 60 mg of Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Avatrombopag: Oral avatrombopag tablet

Study is 2:1 randomization ratio (avatrombopag to placebo). 60 mg Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.

Placebo Oral Tablet: Placebo comparator tablet

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma	NCT00283439	Chemotherapy-In... Hodgkin's Lymph... Non-Hodgkin's L... Cancer Oncology Thrombocytopeni...	AMG 531	18 Years -	Amgen
Avatrombopag vs. Placebo for CIT in GI Malignancies	NCT05772546	Gastrointestina... Gastrointestina... Chemotherapy-In...	Avatrombopag Matching Placeb...	18 Years -	Massachusetts General Hospital
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)	NCT00413283	Lung Cancer Chemotherapy-In... Non-Small Cell ... Cancer Lung Neoplasms Oncology Solid Tumors Thrombocytopeni...	Romiplostim Placebo Gemcitabine Carboplatin Cisplatin	18 Years -	Amgen
Avatrombopag vs. Placebo for CIT in GI Malignancies	NCT05772546	Gastrointestina... Gastrointestina... Chemotherapy-In...	Avatrombopag Matching Placeb...	18 Years -	Massachusetts General Hospital
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma	NCT00283439	Chemotherapy-In... Hodgkin's Lymph... Non-Hodgkin's L... Cancer Oncology Thrombocytopeni...	AMG 531	18 Years -	Amgen
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers	NCT03471078	Chemotherapy-in...	Avatrombopag Placebo Oral Ta...	18 Years -	Sobi, Inc.
Avatrombopag vs. Placebo for CIT in GI Malignancies	NCT05772546	Gastrointestina... Gastrointestina... Chemotherapy-In...	Avatrombopag Matching Placeb...	18 Years -	Massachusetts General Hospital
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)	NCT00413283	Lung Cancer Chemotherapy-In... Non-Small Cell ... Cancer Lung Neoplasms Oncology Solid Tumors Thrombocytopeni...	Romiplostim Placebo Gemcitabine Carboplatin Cisplatin	18 Years -	Amgen

Spots Global Cancer Trial Database for cit

Every month we try and update this database with for cit cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cit

Every month we try and update this database with for cit cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cit cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.